Neurontin 100 mg hard capsules

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Gabapentin

Tilgængelig fra:

Imbat Limited

ATC-kode:

N03AX; N03AX12

INN (International Name):

Gabapentin

Dosering:

100 milligram(s)

Lægemiddelform:

Capsule, hard

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Other antiepileptics; gabapentin

Autorisation status:

Authorised

Autorisation dato:

2014-05-23

Indlægsseddel

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEURONTIN
® 100 MG HARD CAPSULES
(gabapentin)
Your medicine is available using the name Neurontin 100 mg
hard capsules but will be referred to as Neurontin throughout
this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.

If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Neurontin is and what it is used for
2.
What you need to know before you take Neurontin
3.
How to take Neurontin
4.
Possible side effects
5.
How to store Neurontin
6.
Contents of the pack and other information
1.
WHAT NEURONTIN IS AND WHAT IT IS USED FOR
Neurontin belongs to a group of medicines used to treat
epilepsy and peripheral neuropathic pain (long lasting pain
caused by damage to the nerves).
The active substance in Neurontin is gabapentin.
NEURONTIN IS USED TO TREAT

Various forms of epilepsy (seizures that are initially
limited to certain parts of the brain, whether the seizure
spreads to other parts of the brain or not). The doctor
treating you or your child 6 years of age and older will
prescribe Neurontin to help treat epilepsy when the
current treatment is not fully controlling the condition.
You or your child 6 years of age and older should take
Neurontin in addition to the current treatment unless told
otherwise. Neurontin can also be used on its own to treat
adults and children over 12 years of age.

Peripheral neuropathic pain (long lasting pain caused by
damage to the nerves). A variety of different diseases
can cause peripheral neuropathic pain (primarily
occurring in the legs and/or

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neurontin 100 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg hard capsule contains 100 mg of gabapentin.
Excipient(s) with known effect: Lactose (as monohydrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
_Product imported from the United Kingdom:_
A two-piece, white opaque hard gelatin capsule, imprinted with
‘Neurontin 100mg’ and "PD" and containing a white to
off-white powder.
4 CLINICAL PARTICULARS
As per PA0822/015/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/015/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Capsule contents:
Lactose monohydrate
Maize starch
Talc
Capsule shell:
Gelatin
Purified water
Sodium laurilsulfate
Titanium dioxide (E171)
Printing ink:
Shellac
Titanium dioxide (E171)
Indigo carmine (E132)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as
marked in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer carton containing blister strips.
Pack size: 100 hard capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requir